Quality Manager for Regulatory Compliance

hace 4 días


Barcelona, Barcelona, España Fagron Gmbh & Co. Kg A tiempo completo

About the Role

Fagron offers an exciting opportunity for a Quality Manager to join our team and play a key role in ensuring regulatory compliance across our global operations. As a leading player in personalized medical solutions, we are committed to delivering high-quality products and services that meet the evolving needs of our customers.

Key Responsibilities

  • Develop and implement quality management systems to ensure compliance with ISO 14385 & 15189 certification processes.
  • Drive continuous improvement initiatives to enhance quality system processes through Quality Plans, internal audits, and corrective action programs.
  • Support the efficient execution of external audits and inspections, as well as translation of strategy into quality standards.
  • Act as a qualified person for product releases and analyses, while staying up-to-date with national and international legislation and guidelines.
  • Maintain regulatory documentation databases and ensure employee awareness of applicable procedures.
  • Promote good contact with authorities to anticipate changes or new developments in the sector.
  • Plan and monitor training of people in the QMS and communicate the system within the organization.

About You

To be successful in this role, you will possess:

  • A strong background in quality management, with experience in regulatory compliance.
  • Excellent communication and interpersonal skills to effectively collaborate with teams and stakeholders.
  • The ability to think strategically and drive continuous improvement initiatives.
  • Strong analytical and problem-solving skills to identify and resolve compliance issues.

About Fagron

Fagron is a trusted global company established in 1990, with over 2,000 professionals located in 34 countries. We deliver innovative and high-quality personalized solutions that enhance medical compliance and improve healthcare. Our people are driven by passion, a solid scientific core, and a dedication to innovate.

What We Offer

We provide an open and dynamic environment that supports and encourages personal and professional growth. Our salary range for this role is €80,000 - €110,000 per annum, depending on location and experience. We offer a comprehensive benefits package, including opportunities for training and development.



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